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Trial · NCT02533648

Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients

NCT02533648, Phase 3, Completed, Hospices Civils de Lyon

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients. Trials, record NCT02533648. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02533648

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients
NCT number
NCT02533648
Status
Completed
Phases
Phase 3
Enrollment
31 participants, actual
Lead sponsor
Hospices Civils de Lyon
Conditions
Type 2 Diabetes Mellitus
Interventions
2 capsules of allopurinol 150 mg daily for 3 month, 2 capsules of lactose daily for 3 month
First posted
2015-08-27
Last updated
2019-11-01

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarymuscle oxidative stress in diabetic patientsAt 3 months of treatment
muscular protein carbonylation level (unit: reactive carbonyl derivates, arbitrary unit) by Western blot (oxyblot kit from Chemicon) and pro et antioxidant genes expression (unit: mRNA levels normalized by housekeeping gene, arbitrary ratio) by real time polymerase chain reaction (RT-PCR)
Secondary- plasmatic oxidative stress by dosing plasmaticmarkers:At 3 months of treatmentDosing plasmatic malondialdéhyde, plasmatic H2O2, protein carbonylation of plasmatic protein and urinary isoprostans, and finally antioxidants (vitamins C and E, glutathione (unit: from µM to M)
Secondaryalterations in mitochondrial structure of skeletal muscle with transmission electron microscopyAt 3 months of treatmentAnalysis of mitochondria area (in µm2) and density (in %)
Secondarymitochondrial density by measuring the ratio mitochondrial Deoxyribonucleic acid (mtDNA)/nuclear DNA by real-time polymerase chain reaction (PCR) in skeletal muscleAt 3 months of treatment
Secondarymitochondrial functionAt 3 months of treatment
Expression of genes implicated in mitochondrial action (messenger Ribonucleic acid (mRNA) levels by Reverse transcription polymerase chain reaction (RT-PCR) and proteins levels by Western Blot)(unit: arbitrary ratio relative to housekeeping gene/protein).
Secondaryquantification of intramuscular lipids by histology (biopsy analysis)At 3 months of treatmentStaining Oil Red O evaluate the intramuscular lipid accumulation using the software ImageJ(unit: % of labelling by field).
Secondarysensitivity to insulin using a hyperinsulinemic euglycemic clampAt 3 months of treatmentsensitivity to insulin will be expressed as the glucose infusion rate (GIR)/insulinemia ratio.
Secondaryuricemia and xanthine oxidase activity in sera and muscles(unit: mg/l for uricemia and mU/ml for XO activity)At 3 months of treatment
Plasma concentrations of uric acid will be measured before and after treatment to assess patient compliance . The reduction of xanthine oxidase activity in serum and muscle protein lysates will be measured using the kit " Amplex Red xanthine / xanthine oxidase assay kit" from Molecular Probes
SecondaryTolerance of the treatment measured by any adverse events during treatment and between each visit.during the 3 months of treatmentAny adverse events during treatment and between each visit.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02533648

GET https://conductscience.org/api/trials/v1/NCT02533648/registered